Analyte Monitoring System and Methods

ABSTRACT

Methods and systems for providing data communication in medical systems are disclosed.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 13/089,309 filed Apr. 18, 2011, entitled “Analyte MonitoringSystem and Methods”, which is a continuation of U.S. patent applicationSer. No. 12/117,665 filed May 8, 2008, now U.S. Pat. No. 7,928,850,which claims priority to U.S. provisional application No. 60/916,677filed May 8, 2007, entitled “Analyte Monitoring System and Methods”, thedisclosures of each of which are incorporated herein by reference forall purposes.

BACKGROUND

Analyte, e.g., glucose monitoring systems including continuous anddiscrete monitoring systems generally include a small, lightweightbattery powered and microprocessor controlled system which is configuredto detect signals proportional to the corresponding measured glucoselevels using an electrometer. Radio frequency (RF) signals may be usedto transmit the collected data. One aspect of certain analyte monitoringsystems include a transcutaneous or subcutaneous analyte sensorconfiguration which is, for example, at least partially positionedthrough the skin layer of a subject whose analyte level is to bemonitored. The sensor may use a two or three-electrode (work, referenceand counter electrodes) configuration driven by a controlled potential(potentiostat) analog circuit connected through a contact system.

An analyte sensor may be configured so that a portion thereof is placedunder the skin of the patient so as to contact analyte of the patient,and another portion or segment of the analyte sensor may be incommunication with the transmitter unit. The transmitter unit may beconfigured to transmit the analyte levels detected by the sensor over awireless communication link such as an RF (radio frequency)communication link to a receiver/monitor unit. The receiver/monitor unitmay perform data analysis, among other functions, on the receivedanalyte levels to generate information pertaining to the monitoredanalyte levels.

Transmission of control or command data over wireless communication linkis often constrained to occur within a substantially short timeduration. In turn, the time constraint in data communication imposeslimits on the type and size of data that may be transmitted during thetransmission time period.

In view of the foregoing, it would be desirable to have a method andapparatus for optimizing the RF communication link between two or morecommunication devices, for example, in a medical communication system.

SUMMARY

Devices and methods for analyte monitoring, e.g., glucose monitoring,are provided. Embodiments include transmitting information from a firstlocation to a second, e.g., using a telemetry system such as RFtelemetry. Systems herein include continuous analyte monitoring systemsand discrete analyte monitoring system.

In one embodiment, a method including periodically receiving dataincluding a count information related to an analyte sensor associatedwith the received data, and comparing the count information in each dataperiodically received, and when it is determined that the countinformation of the periodically received data is different, generatingone or more signals related to the status of the analyte sensor, isdisclosed, as well as devices and systems for the same.

These and other objects, features and advantages of the presentinvention will become more fully apparent from the following detaileddescription of the embodiments, the appended claims and the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a block diagram of a data monitoring and managementsystem for practicing one or more embodiments of the present invention;

FIG. 2 is a block diagram of the transmitter unit of the data monitoringand management system shown in FIG. 1 in accordance with one embodimentof the present invention;

FIG. 3 is a block diagram of the receiver/monitor unit of the datamonitoring and management system shown in FIG. 1 in accordance with oneembodiment of the present invention;

FIG. 4 is a flowchart illustrating data packet procedure includingrolling data for transmission in accordance with one embodiment of thepresent invention;

FIG. 5 is a flowchart illustrating data processing of the received datapacket including the rolling data in accordance with one embodiment ofthe present invention;

FIG. 6 is a block diagram illustrating the sensor unit and thetransmitter unit of the data monitoring and management system of FIG. 1in accordance with one embodiment of the present invention;

FIG. 7 is a flowchart illustrating data communication using closeproximity commands in the data monitoring and management system of FIG.1 in accordance with one embodiment of the present invention;

FIG. 8 is a flowchart illustrating sensor insertion detection routine inthe data monitoring and management system of FIG. 1 in accordance withone embodiment of the present invention;

FIG. 9 is a flowchart illustrating sensor removal detection routine inthe data monitoring and management system of FIG. 1 in accordance withone embodiment of the present invention;

FIG. 10 is a flowchart illustrating the pairing or synchronizationroutine in the data monitoring and management system of FIG. 1 inaccordance with one embodiment of the present invention;

FIG. 11 is a flowchart illustrating the pairing or synchronizationroutine in the data monitoring and management system of FIG. 1 inaccordance with another embodiment of the present invention;

FIG. 12 is a flowchart illustrating the power supply determination inthe data monitoring and management system of FIG. 1 in accordance withone embodiment of the present invention;

FIG. 13 is a flowchart illustrating close proximity command for RFcommunication control in the data monitoring and management system ofFIG. 1 in accordance with one embodiment of the present invention; and

FIG. 14 is a flowchart illustrating analyte sensor identificationroutine in accordance with one embodiment of the present invention.

DETAILED DESCRIPTION

As summarized above and as described in further detail below, inaccordance with the various embodiments of the present invention, thereis provided a method and system periodically receiving data including acount information related to an analyte sensor associated with thereceived data, and comparing the count information in each dataperiodically received, and when it is determined that the countinformation of the periodically received data is different, generatingone or more signals related to the status of the analyte sensor.

FIG. 1 illustrates a data monitoring and management system such as, forexample, analyte (e.g., glucose) monitoring system 100 in accordancewith one embodiment of the present invention. The subject invention isfurther described primarily with respect to a glucose monitoring systemfor convenience and such description is in no way intended to limit thescope of the invention. It is to be understood that the analytemonitoring system may be configured to monitor a variety of analytes,e.g., lactate, and the like.

Analytes that may be monitored include, for example, acetyl choline,amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase(e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growthhormones, hormones, ketones, lactate, peroxide, prostate-specificantigen, prothrombin, RNA, thyroid stimulating hormone, and troponin.The concentration of drugs, such as, for example, antibiotics (e.g.,gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs ofabuse, theophylline, and warfarin, may also be monitored. More than oneanalyte may be monitored by a single system, e.g. a single analytesensor.

The analyte monitoring system 100 includes a sensor unit 101, atransmitter unit 102 coupleable to the sensor unit 101, and a primaryreceiver unit 104 which is configured to communicate with thetransmitter unit 102 via a bi-directional communication link 103. Theprimary receiver unit 104 may be further configured to transmit data toa data processing terminal 105 for evaluating the data received by theprimary receiver unit 104. Moreover, the data processing terminal 105 inone embodiment may be configured to receive data directly from thetransmitter unit 102 via a communication link which may optionally beconfigured for bi-directional communication. Accordingly, transmitterunit 102 and/or receiver unit 104 may include a transceiver.

Also shown in FIG. 1 is an optional secondary receiver unit 106 which isoperatively coupled to the communication link and configured to receivedata transmitted from the transmitter unit 102. Moreover, as shown inthe Figure, the secondary receiver unit 106 is configured to communicatewith the primary receiver unit 104 as well as the data processingterminal 105. Indeed, the secondary receiver unit 106 may be configuredfor bi-directional wireless communication with each or one of theprimary receiver unit 104 and the data processing terminal 105. Asdiscussed in further detail below, in one embodiment of the presentinvention, the secondary receiver unit 106 may be configured to includea limited number of functions and features as compared with the primaryreceiver unit 104. As such, the secondary receiver unit 106 may beconfigured substantially in a smaller compact housing or embodied in adevice such as a wrist watch, pager, mobile phone, PDA, for example.Alternatively, the secondary receiver unit 106 may be configured withthe same or substantially similar functionality as the primary receiverunit 104. The receiver unit may be configured to be used in conjunctionwith a docking cradle unit, for example for one or more of the followingor other functions: placement by bedside, for re-charging, for datamanagement, for night time monitoring, and/or bi-directionalcommunication device.

In one aspect sensor unit 101 may include two or more sensors, eachconfigured to communicate with transmitter unit 102. Furthermore, whileonly one, transmitter unit 102, communication link 103, and dataprocessing terminal 105 are shown in the embodiment of the analytemonitoring system 100 illustrated in FIG. 1. However, it will beappreciated by one of ordinary skill in the art that the analytemonitoring system 100 may include one or more sensors, multipletransmitter units 102, communication links 103, and data processingterminals 105. Moreover, within the scope of the present invention, theanalyte monitoring system 100 may be a continuous monitoring system, orsemi-continuous, or a discrete monitoring system. In a multi-componentenvironment, each device is configured to be uniquely identified by eachof the other devices in the system so that communication conflict isreadily resolved between the various components within the analytemonitoring system 100.

In one embodiment of the present invention, the sensor unit 101 isphysically positioned in or on the body of a user whose analyte level isbeing monitored. The sensor unit 101 may be configured to continuouslysample the analyte level of the user and convert the sampled analytelevel into a corresponding data signal for transmission by thetransmitter unit 102. In certain embodiments, the transmitter unit 102may be physically coupled to the sensor unit 101 so that both devicesare integrated in a single housing and positioned on the user's body.The transmitter unit 102 may perform data processing such as filteringand encoding on data signals and/or other functions, each of whichcorresponds to a sampled analyte level of the user, and in any eventtransmitter unit 102 transmits analyte information to the primaryreceiver unit 104 via the communication link 103.

In one embodiment, the analyte monitoring system 100 is configured as aone-way RF communication path from the transmitter unit 102 to theprimary receiver unit 104. In such embodiment, the transmitter unit 102transmits the sampled data signals received from the sensor unit 101without acknowledgement from the primary receiver unit 104 that thetransmitted sampled data signals have been received. For example, thetransmitter unit 102 may be configured to transmit the encoded sampleddata signals at a fixed rate (e.g., at one minute intervals) after thecompletion of the initial power on procedure. Likewise, the primaryreceiver unit 104 may be configured to detect such transmitted encodedsampled data signals at predetermined time intervals. Alternatively, theanalyte monitoring system 100 may be configured with a bi-directional RF(or otherwise) communication between the transmitter unit 102 and theprimary receiver unit 104.

Additionally, in one aspect, the primary receiver unit 104 may includetwo sections. The first section is an analog interface section that isconfigured to communicate with the transmitter unit 102 via thecommunication link 103. In one embodiment, the analog interface sectionmay include an RF receiver and an antenna for receiving and amplifyingthe data signals from the transmitter unit 102, which are thereafter,demodulated with a local oscillator and filtered through a band-passfilter. The second section of the primary receiver unit 104 is a dataprocessing section which is configured to process the data signalsreceived from the transmitter unit 102 such as by performing datadecoding, error detection and correction, data clock generation, anddata bit recovery.

In operation, upon completing the power-on procedure, the primaryreceiver unit 104 is configured to detect the presence of thetransmitter unit 102 within its range based on, for example, thestrength of the detected data signals received from the transmitter unit102 and/or a predetermined transmitter identification information. Uponsuccessful synchronization with the corresponding transmitter unit 102,the primary receiver unit 104 is configured to begin receiving from thetransmitter unit 102 data signals corresponding to the user's detectedanalyte level. More specifically, the primary receiver unit 104 in oneembodiment is configured to perform synchronized time hopping with thecorresponding synchronized transmitter unit 102 via the communicationlink 103 to obtain the user's detected analyte level.

Referring again to FIG. 1, the data processing terminal 105 may includea personal computer, a portable computer such as a laptop or a handhelddevice (e.g., personal digital assistants (PDAs)), and the like, each ofwhich may be configured for data communication with the receiver via awired or a wireless connection. Additionally, the data processingterminal 105 may further be connected to a data network (not shown) forstoring, retrieving and updating data corresponding to the detectedanalyte level of the user.

Within the scope of the present invention, the data processing terminal105 may include an infusion device such as an insulin infusion pump(external or implantable) or the like, which may be configured toadminister insulin to patients, and which may be configured tocommunicate with the receiver unit 104 for receiving, among others, themeasured analyte level. Alternatively, the receiver unit 104 may beconfigured to integrate or otherwise couple to an infusion devicetherein so that the receiver unit 104 is configured to administerinsulin therapy to patients, for example, for administering andmodifying basal profiles, as well as for determining appropriate bolusesfor administration based on, among others, the detected analyte levelsreceived from the transmitter unit 102.

Additionally, the transmitter unit 102, the primary receiver unit 104and the data processing terminal 105 may each be configured forbi-directional wireless communication such that each of the transmitterunit 102, the primary receiver unit 104 and the data processing terminal105 may be configured to communicate (that is, transmit data to andreceive data from) with each other via the wireless communication link103. More specifically, the data processing terminal 105 may in oneembodiment be configured to receive data directly from the transmitterunit 102 via a communication link, where the communication link, asdescribed above, may be configured for bi-directional communication.

In this embodiment, the data processing terminal 105 which may includean insulin pump, may be configured to receive the analyte signals fromthe transmitter unit 102, and thus, incorporate the functions of thereceiver 104 including data processing for managing the patient'sinsulin therapy and analyte monitoring. In one embodiment, thecommunication link 103 may include one or more of an RF communicationprotocol, an infrared communication protocol, a Bluetooth® enabledcommunication protocol, an 802.11x wireless communication protocol, oran equivalent wireless communication protocol which would allow secure,wireless communication of several units (for example, per HIPAArequirements) while avoiding potential data collision and interference.

FIG. 2 is a block diagram of the transmitter of the data monitoring anddetection system shown in FIG. 1 in accordance with one embodiment ofthe present invention. Referring to the Figure, the transmitter unit 102in one embodiment includes an analog interface 201 configured tocommunicate with the sensor unit 101 (FIG. 1), a user input 202, and atemperature detection section 203, each of which is operatively coupledto a transmitter processor 204 such as a central processing unit (CPU).As can be seen from FIG. 2, there are provided four contacts, three ofwhich are electrodes—work electrode (W) 210, guard contact (G) 211,reference electrode (R) 212, and counter electrode (C) 213, eachoperatively coupled to the analog interface 201 of the transmitter unit102 for connection to the sensor unit 101 (FIG. 1). In one embodiment,each of the work electrode (W) 210, guard contact (G) 211, referenceelectrode (R) 212, and counter electrode (C) 213 may be made using aconductive material that is either printed or etched or ablated, forexample, such as carbon which may be printed, or a metal such as a metalfoil (e.g., gold) or the like, which may be etched or ablated orotherwise processed to provide one or more electrodes. Fewer or greaterelectrodes and/or contact may be provided in certain embodiments.

Further shown in FIG. 2 are a transmitter serial communication section205 and an RF transmitter 206, each of which is also operatively coupledto the transmitter processor 204. Moreover, a power supply 207 such as abattery is also provided in the transmitter unit 102 to provide thenecessary power for the transmitter unit 102. Additionally, as can beseen from the Figure, clock 208 is provided to, among others, supplyreal time information to the transmitter processor 204.

In one embodiment, a unidirectional input path is established from thesensor unit 101 (FIG. 1) and/or manufacturing and testing equipment tothe analog interface 201 of the transmitter unit 102, while aunidirectional output is established from the output of the RFtransmitter 206 of the transmitter unit 102 for transmission to theprimary receiver unit 104. In this manner, a data path is shown in FIG.2 between the aforementioned unidirectional input and output via adedicated link 209 from the analog interface 201 to serial communicationsection 205, thereafter to the processor 204, and then to the RFtransmitter 206. As such, in one embodiment, via the data path describedabove, the transmitter unit 102 is configured to transmit to the primaryreceiver unit 104 (FIG. 1), via the communication link 103 (FIG. 1),processed and encoded data signals received from the sensor unit 101(FIG. 1). Additionally, the unidirectional communication data pathbetween the analog interface 201 and the RF transmitter 206 discussedabove allows for the configuration of the transmitter unit 102 foroperation upon completion of the manufacturing process as well as fordirect communication for diagnostic and testing purposes.

As discussed above, the transmitter processor 204 is configured totransmit control signals to the various sections of the transmitter unit102 during the operation of the transmitter unit 102. In one embodiment,the transmitter processor 204 also includes a memory (not shown) forstoring data such as the identification information for the transmitterunit 102, as well as the data signals received from the sensor unit 101.The stored information may be retrieved and processed for transmissionto the primary receiver unit 104 under the control of the transmitterprocessor 204. Furthermore, the power supply 207 may include acommercially available battery, which may be a rechargeable battery.

In certain embodiments, the transmitter unit 102 is also configured suchthat the power supply section 207 is capable of providing power to thetransmitter for a minimum of about three months of continuous operation,e.g., after having been stored for about eighteen months such as storedin a low-power (non-operating) mode. In one embodiment, this may beachieved by the transmitter processor 204 operating in low power modesin the non-operating state, for example, drawing no more thanapproximately 1 μA of current. Indeed, in one embodiment, a step duringthe manufacturing process of the transmitter unit 102 may place thetransmitter unit 102 in the lower power, non-operating state (i.e.,post-manufacture sleep mode). In this manner, the shelf life of thetransmitter unit 102 may be significantly improved. Moreover, as shownin FIG. 2, while the power supply unit 207 is shown as coupled to theprocessor 204, and as such, the processor 204 is configured to providecontrol of the power supply unit 207, it should be noted that within thescope of the present invention, the power supply unit 207 is configuredto provide the necessary power to each of the components of thetransmitter unit 102 shown in FIG. 2.

Referring back to FIG. 2, the power supply section 207 of thetransmitter unit 102 in one embodiment may include a rechargeablebattery unit that may be recharged by a separate power supply rechargingunit (for example, provided in the receiver unit 104) so that thetransmitter unit 102 may be powered for a longer period of usage time.Moreover, in one embodiment, the transmitter unit 102 may be configuredwithout a battery in the power supply section 207, in which case thetransmitter unit 102 may be configured to receive power from an externalpower supply source (for example, a battery) as discussed in furtherdetail below.

Referring yet again to FIG. 2, the temperature detection section 203 ofthe transmitter unit 102 is configured to monitor the temperature of theskin near the sensor insertion site. The temperature reading is used toadjust the analyte readings obtained from the analog interface 201. Incertain embodiments, the RF transmitter 206 of the transmitter unit 102may be configured for operation in the frequency band of approximately315 MHz to approximately 322 MHz, for example, in the United States. Incertain embodiments, the RF transmitter 206 of the transmitter unit 102may be configured for operation in the frequency band of approximately400 MHz to approximately 470 MHz. Further, in one embodiment, the RFtransmitter 206 is configured to modulate the carrier frequency byperforming Frequency Shift Keying and Manchester encoding. In oneembodiment, the data transmission rate is about 19,200 symbols persecond, with a minimum transmission range for communication with theprimary receiver unit 104.

Referring yet again to FIG. 2, also shown is a leak detection circuit214 coupled to the guard electrode (G) 211 and the processor 204 in thetransmitter unit 102 of the data monitoring and management system 100.The leak detection circuit 214 in accordance with one embodiment of thepresent invention may be configured to detect leakage current in thesensor unit 101 to determine whether the measured sensor data arecorrupt or whether the measured data from the sensor 101 is accurate.Exemplary analyte systems that may be employed are described in, forexample, U.S. Pat. Nos. 6,134,461, 6,175,752, 6,121,611, 6,560,471,6,746,582, and elsewhere, the disclosure of each of which areincorporated by reference for all purposes.

FIG. 3 is a block diagram of the receiver/monitor unit of the datamonitoring and management system shown in FIG. 1 in accordance with oneembodiment of the present invention. Referring to FIG. 3, the primaryreceiver unit 104 includes an analyte test strip, e.g., blood glucosetest strip, interface 301, an RF receiver 302, an input 303, atemperature detection section 304, and a clock 305, each of which isoperatively coupled to a receiver processor 307. As can be further seenfrom the Figure, the primary receiver unit 104 also includes a powersupply 306 operatively coupled to a power conversion and monitoringsection 308. Further, the power conversion and monitoring section 308 isalso coupled to the receiver processor 307. Moreover, also shown are areceiver serial communication section 309, and an output 310, eachoperatively coupled to the receiver processor 307.

In one embodiment, the test strip interface 301 includes a glucose leveltesting portion to receive a manual insertion of a glucose test strip,and thereby determine and display the glucose level of the test strip onthe output 310 of the primary receiver unit 104. This manual testing ofglucose may be used to calibrate the sensor unit 101 or otherwise. TheRF receiver 302 is configured to communicate, via the communication link103 (FIG. 1) with the RF transmitter 206 of the transmitter unit 102, toreceive encoded data signals from the transmitter unit 102 for, amongothers, signal mixing, demodulation, and other data processing. Theinput 303 of the primary receiver unit 104 is configured to allow theuser to enter information into the primary receiver unit 104 as needed.In one aspect, the input 303 may include one or more keys of a keypad, atouch-sensitive screen, or a voice-activated input command unit. Thetemperature detection section 304 is configured to provide temperatureinformation of the primary receiver unit 104 to the receiver processor307, while the clock 305 provides, among others, real time informationto the receiver processor 307.

Each of the various components of the primary receiver unit 104 shown inFIG. 3 is powered by the power supply 306 which, in one embodiment,includes a battery. Furthermore, the power conversion and monitoringsection 308 is configured to monitor the power usage by the variouscomponents in the primary receiver unit 104 for effective powermanagement and to alert the user, for example, in the event of powerusage which renders the primary receiver unit 104 in sub-optimaloperating conditions. An example of such sub-optimal operating conditionmay include, for example, operating the vibration output mode (asdiscussed below) for a period of time thus substantially draining thepower supply 306 while the processor 307 (thus, the primary receiverunit 104) is turned on. Moreover, the power conversion and monitoringsection 308 may additionally be configured to include a reverse polarityprotection circuit such as a field effect transistor (FET) configured asa battery activated switch.

The serial communication section 309 in the primary receiver unit 104 isconfigured to provide a bi-directional communication path from thetesting and/or manufacturing equipment for, among others,initialization, testing, and configuration of the primary receiver unit104. Serial communication section 309 can also be used to upload data toa computer, such as time-stamped blood glucose data. The communicationlink with an external device (not shown) can be made, for example, bycable, infrared (IR) or RF link. The output 310 of the primary receiverunit 104 is configured to provide, among others, a graphical userinterface (GUI) such as a liquid crystal display (LCD) for displayinginformation. Additionally, the output 310 may also include an integratedspeaker for outputting audible signals as well as to provide vibrationoutput as commonly found in handheld electronic devices, such as mobiletelephones presently available. In a further embodiment, the primaryreceiver unit 104 also includes an electro-luminescent lamp configuredto provide backlighting to the output 310 for output visual display indark ambient surroundings.

Referring back to FIG. 3, the primary receiver unit 104 in oneembodiment may also include a storage section such as a programmable,non-volatile memory device as part of the processor 307, or providedseparately in the primary receiver unit 104, operatively coupled to theprocessor 307. The processor 307 may be configured to synchronize with atransmitter, e.g., using Manchester decoding or the like, as well aserror detection and correction upon the encoded data signals receivedfrom the transmitter unit 102 via the communication link 103.

Additional description of the RF communication between the transmitter102 and the primary receiver 104 (or with the secondary receiver 106)that may be employed in embodiments of the subject invention isdisclosed in pending application Ser. No. 11/060,365 filed Feb. 16, 2005entitled “Method and System for Providing Data Communication inContinuous Glucose Monitoring and Management System” the disclosure ofwhich is incorporated herein by reference for all purposes.

Referring to the Figures, in one embodiment, the transmitter 102(FIG. 1) may be configured to generate data packets for periodictransmission to one ore more of the receiver units 104, 106, where eachdata packet includes in one embodiment two categories of data—urgentdata and non-urgent data. For example, urgent data such as for exampleglucose data from the sensor and/or temperature data associated with thesensor may be packed in each data packet in addition to non-urgent data,where the non-urgent data is rolled or varied with each data packettransmission.

That is, the non-urgent data is transmitted at a timed interval so as tomaintain the integrity of the analyte monitoring system without beingtransmitted over the RF communication link with each data transmissionpacket from the transmitter 102. In this manner, the non-urgent data,for example that are not time sensitive, may be periodically transmitted(and not with each data packet transmission) or broken up intopredetermined number of segments and sent or transmitted over multiplepackets, while the urgent data is transmitted substantially in itsentirety with each data transmission.

Referring again to the Figures, upon receiving the data packets from thetransmitter 102, the one or more receiver units 104, 106 may beconfigured to parse the received the data packet to separate the urgentdata from the non-urgent data, and also, may be configured to store theurgent data and the non-urgent data, e.g., in a hierarchical manner. Inaccordance with the particular configuration of the data packet or thedata transmission protocol, more or less data may be transmitted as partof the urgent data, or the non-urgent rolling data. That is, within thescope of the present disclosure, the specific data packet implementationsuch as the number of bits per packet, and the like, may vary based on,among others, the communication protocol, data transmission time window,and so on.

In an exemplary embodiment, different types of data packets may beidentified accordingly. For example, identification in certain exemplaryembodiments may include—(1) single sensor, one minute of data, (2) twoor multiple sensors, (3) dual sensor, alternate one minute data, and (4)response packet. For single sensor one minute data packet, in oneembodiment, the transmitter 102 may be configured to generate the datapacket in the manner, or similar to the manner, shown in Table 1 below.

TABLE 1 Single sensor, one minute of data Number of Bits Data Field 8Transmit Time 14 Sensor1 Current Data 14 Sensor1 Historic Data 8Transmit Status 12 AUX Counter 12 AUX Thermistor 1 12 AUX Thermistor 2 8Rolling-Data-1

As shown in Table 1 above, the transmitter data packet in one embodimentmay include 8 bits of transmit time data, 14 bits of current sensordata, 14 bits of preceding sensor data, 8 bits of transmitter statusdata, 12 bits of auxiliary counter data, 12 bits of auxiliary thermistor1 data, 12 bits of auxiliary thermistor 2 data and 8 bits of rollingdata. In one embodiment of the present invention, the data packetgenerated by the transmitter for transmission over the RF communicationlink may include all or some of the data shown above in Table 1.

Referring back, the 14 bits of the current sensor data provides the realtime or current sensor data associated with the detected analyte level,while the 14 bits of the sensor historic or preceding sensor dataincludes the sensor data associated with the detected analyte level oneminute ago. In this manner, in the case where the receiver unit 104, 106drops or fails to successfully receive the data packet from thetransmitter 102 in the minute by minute transmission, the receiver unit104, 106 may be able to capture the sensor data of a prior minutetransmission from a subsequent minute transmission.

Referring again to Table 1, the Auxiliary data in one embodiment mayinclude one or more of the patient's skin temperature data, atemperature gradient data, reference data, and counter electrodevoltage. The transmitter status field may include status data that isconfigured to indicate corrupt data for the current transmission (forexample, if shown as BAD status (as opposed to GOOD status whichindicates that the data in the current transmission is not corrupt)).Furthermore, the rolling data field is configured to include thenon-urgent data, and in one embodiment, may be associated with thetime-hop sequence number. In addition, the Transmitter Time field in oneembodiment includes a protocol value that is configured to start at zeroand is incremented by one with each data packet. In one aspect, thetransmitter time data may be used to synchronize the data transmissionwindow with the receiver unit 104, 106, and also, provide an index forthe Rolling data field.

In a further embodiment, the transmitter data packet may be configuredto provide or transmit analyte sensor data from two or more independentanalyte sensors. The sensors may relate to the same or different analyteor property. In such a case, the data packet from the transmitter 102may be configured to include 14 bits of the current sensor data fromboth sensors in the embodiment in which 2 sensors are employed. In thiscase, the data packet does not include the immediately preceding sensordata in the current data packet transmission. Instead, a second analytesensor data is transmitted with a first analyte sensor data.

TABLE 2 Dual sensor data Number of Bits Data Field 8 Transmit Time 14Sensor1 Current Data 14 Sensor2 Current Data 8 Transmit Status 12 AUXCounter 12 AUX Thermistor 1 12 AUX Thermistor 2 8 Rolling-Data-1

In a further embodiment, the transmitter data packet may be alternatedwith each transmission between two analyte sensors, for example,alternating between the data packet shown in Table 3 and Table 4 below.

TABLE 3 Sensor Data Packet Alternate 1 Number of Bits Data Field 8Transmitter Time 14 Sensor1 Current Data 14 Sensor1 Historic Data 8Transmit Status 12 AUX Counter 12 AUX Thermistor 1 12 AUX Thermistor 2 8Rolling-Data-1

TABLE 4 Sensor Data Packet Alternate 2 Number of Bits Data Field 8Transmitter Time 14 Sensor1 Current Data 14 Sensor2 Current Data 8Transmit Status 12 AUX Counter 12 AUX Thermistor 1 12 AUX Thermistor 2 8Rolling-Data-1

As shown above in reference to Tables 3 and 4, the minute by minute datapacket transmission from the transmitter 102 (FIG. 1) in one embodimentmay alternate between the data packet shown in Table 3 and the datapacket shown in Table 4. More specifically, the transmitter 102 may beconfigured in one embodiment transmit the current sensor data of thefirst sensor and the preceding sensor data of the first sensor (Table3), as well as the rolling data, and further, at the subsequenttransmission, the transmitter 102 may be configured to transmit thecurrent sensor data of the first and the second sensor in addition tothe rolling data.

In one embodiment, the rolling data transmitted with each data packetmay include a sequence of various predetermined types of data that areconsidered not-urgent or not time sensitive. That is, in one embodiment,the following list of data shown in Table 5 may be sequentially includedin the 8 bits of transmitter data packet, and not transmitted with eachdata packet transmission of the transmitter (for example, with each 60second data transmission from the transmitter 102).

TABLE 5 Rolling Data Time Slot Bits Rolling-Data 0 8 Mode 1 8 Glucose1Slope 2 8 Glucose2 Slope 3 8 Ref-R 4 8 Hobbs Counter, Ref-R 5 8 HobbsCounter 6 8 Hobbs Counter 7 8 Sensor Count

As can be seen from Table 5 above, in one embodiment, a sequence ofrolling data are appended or added to the transmitter data packet witheach data transmission time slot. In one embodiment, there may be 256time slots for data transmission by the transmitter 102 (FIG. 1), andwhere, each time slot is separated by approximately 60 second interval.For example, referring to the Table 5 above, the data packet intransmission time slot 0 (zero) may include operational mode data (Mode)as the rolling data that is appended to the transmitted data packet. Atthe subsequent data transmission time slot (for example, approximately60 seconds after the initial time slot (0)), the transmitted data packetmay include the analyte sensor 1 calibration factor information(Glucosel slope) as the rolling data. In this manner, with each datatransmission, the rolling data may be updated over the 256 time slotcycle.

Referring again to Table 5, each rolling data field is described infurther detail for various embodiments. For example, the Mode data mayinclude information related to the different operating modes such as,but not limited to, the data packet type, the type of battery used,diagnostic routines, single sensor or multiple sensor input, type ofdata transmission (rf communication link or other data link such asserial connection). Further, the Glucosel-slope data may include an8-bit scaling factor or calibration data for first sensor (scalingfactor for sensor 1 data), while Glucose2-slope data may include an8-bit scaling factor or calibration data for the second analyte sensor(in the embodiment including more than one analyte sensors).

In addition, the Ref-R data may include 12 bits of on-board referenceresistor used to calibrate our temperature measurement in the thermistercircuit (where 8 bits are transmitted in time slot 3, and the remaining4 bits are transmitted in time slot 4), and the 20-bit Hobbs counterdata may be separately transmitted in three time slots (for example, intime slot 4, time slot 5 and time slot 6) to add up to 20 bits. In oneembodiment, the Hobbs counter may be configured to count each occurrenceof the data transmission (for example, a packet transmission atapproximately 60 second intervals) and may be incremented by a count ofone (1).

In one aspect, the Hobbs counter is stored in a nonvolatile memory ofthe transmitter unit 102 (FIG. 1) and may be used to ascertain the powersupply status information such as, for example, the estimated batterylife remaining in the transmitter unit 102. That is, with each sensorreplacement, the Hobbs counter is not reset, but rather, continues thecount with each replacement of the sensor unit 101 to establish contactwith the transmitter unit 102 such that, over an extended usage timeperiod of the transmitter unit 102, it may be possible to determine,based on the Hobbs count information, the amount of consumed batterylife in the transmitter unit 102, and also, an estimated remaining lifeof the battery in the transmitter unit 102.

That is, in one embodiment, the 20 bit Hobbs counter is incremented byone each time the transmitter unit 102 transmits a data packet (forexample, approximately each 60 seconds), and based on the countinformation in the Hobbs counter, in one aspect, the battery life of thetransmitter unit 102 may be estimated. In this manner, in configurationsof the transmitter unit 620 (see FIG. 6) where the power supply is not areplaceable component but rather, embedded within the housing thetransmitter unit 620, it is possible to estimate the remaining life ofthe embedded battery within the transmitter unit 620. Moreover, theHobbs counter is configured to remain persistent in the memory device ofthe transmitter unit 620 such that, even when the transmitter unit poweris turned off or powered down (for example, during the periodic sensorunit replacement, RF transmission turned off period and the like), theHobbs counter information is retained.

Referring to Table 5 above, the transmitted rolling data may alsoinclude 8 bits of sensor count information (for example, transmitted intime slot 7). The 8 bit sensor counter is incremented by one each time anew sensor unit is connected to the transmitter unit. The ASICconfiguration of the transmitter unit (or a microprocessor basedtransmitter configuration or with discrete components) may be configuredto store in a nonvolatile memory unit the sensor count information andtransmit it to the primary receiver unit 104 (for example). In turn, theprimary receiver unit 104 (and/or the secondary receiver unit 106) maybe configured to determine whether it is receiving data from thetransmitter unit that is associated with the same sensor unit (based onthe sensor count information), or from a new or replaced sensor unit(which will have a sensor count incremented by one from the prior sensorcount). In this manner, in one aspect, the receiver unit (primary orsecondary) may be configured to prevent reuse of the same sensor unit bythe user based on verifying the sensor count information associated withthe data transmission received from the transmitter unit 102. Inaddition, in a further aspect, user notification may be associated withone or more of these parameters. Further, the receiver unit (primary orsecondary) may be configured to detect when a new sensor has beeninserted, and thus prevent erroneous application of one or morecalibration parameters determined in conjunction with a prior sensor,that may potentially result in false or inaccurate analyte leveldetermination based on the sensor data.

FIG. 4 is a flowchart illustrating a data packet procedure includingrolling data for transmission in accordance with one embodiment of thepresent invention. Referring to FIG. 4, in one embodiment, a counter isinitialized (for example, to T=0) (410). Thereafter the associatedrolling data is retrieved from memory device, for example (420), andalso, the time sensitive or urgent data is retrieved (430). In oneembodiment, the retrieval of the rolling data (420) and the retrieval ofthe time sensitive data (430) may be retrieved at substantially the sametime.

Referring back to FIG. 4, with the rolling data and the time sensitivedata, for example, the data packet for transmission is generated (440),and upon transmission, the counter is incremented by one (450) and theroutine returns to retrieval of the rolling data (420). In this manner,in one embodiment, the urgent time sensitive data as well as thenon-urgent data may be incorporated in the same data packet andtransmitted by the transmitter 102 (FIG. 1) to a remote device such asone or more of the receivers 104, 106. Furthermore, as discussed above,the rolling data may be updated at a predetermined time interval whichis longer than the time interval for each data packet transmission fromthe transmitter 102 (FIG. 1).

FIG. 5 is a flowchart illustrating data processing of the received datapacket including the rolling data in accordance with one embodiment ofthe present invention. Referring to FIG. 5, when the data packet isreceived (510) (for example, by one or more of the receivers 104, 106,in one embodiment, the received data packet is parsed so that the urgentdata may be separated from the not-urgent data (stored in, for example,the rolling data field in the data packet) (520). Thereafter the parseddata is suitably stored in an appropriate memory or storage device(530).

In the manner described above, in accordance with one embodiment of thepresent invention, there is provided method and apparatus for separatingnon-urgent type data (for example, data associated with calibration)from urgent type data (for example, monitored analyte related data) tobe transmitted over the communication link to minimize the potentialburden or constraint on the available transmission time. Morespecifically, in one embodiment, non-urgent data may be separated fromdata that is required by the communication system to be transmittedimmediately, and transmitted over the communication link together whilemaintaining a minimum transmission time window. In one embodiment, thenon-urgent data may be parsed or broken up in to a number of datasegments, and transmitted over multiple data packets. The time sensitiveimmediate data (for example, the analyte sensor data, temperature dataetc.) may be transmitted over the communication link substantially inits entirety with each data packet or transmission.

FIG. 6 is a block diagram illustrating the sensor unit and thetransmitter unit of the data monitoring and management system of FIG. 1in accordance with one embodiment of the present invention. Referring toFIG. 6, in one aspect, a transmitter unit 620 is provided in asubstantially water tight and sealed housing. The transmitter unit 620includes respective contacts (wrk, ref, cntr, and grd) for respectivelyestablishing electrical contact with one or more of the workingelectrode, the reference electrode, the counter electrode and the groundterminal (or guard trace) of the sensor unit 610. Also shown in FIG. 6is a conductivity bar/trace 611 provided on the sensor unit 610. Forexample, in one embodiment, the conductivity bar/trace 611 may comprisea carbon trace on a substrate layer of the sensor unit 610. In thismanner, in one embodiment, when the sensor unit 610 is coupled to thetransmitter unit 620, electrical contact is established, for example,via the conductivity bar/trace 611 between the contact pads or points ofthe transmitter unit 620 (for example, at the counter electrode contact(cntr) and the ground terminal contact (grd) such that the transmitterunit 620 may be powered for data communication.

That is, during manufacturing of the transmitter unit 620, in oneaspect, the transmitter unit 620 is configured to include a power supplysuch as battery 621. Further, during the initial non-use period (e.g.,post manufacturing sleep mode), the transmitter unit 620 is configuredsuch that it is not used and thus drained by the components of thetransmitter unit 620. During the sleep mode, and prior to establishingelectrical contact with the sensor unit 610 via the conductivitybar/trace 611, the transmitter unit 620 is provided with a low powersignal from, for example, a low power voltage comparator 622, via anelectronic switch 623 to maintain the low power state of, for example,the transmitter unit 620 components. Thereafter, upon connection withthe sensor unit 610, and establishing electrical contact via theconductivity bar/trace 611, the embedded power supply 621 of thetransmitter unit 620 is activated or powered up so that some of all ofthe components of the transmitter unit 620 are configured to receive thenecessary power signals for operations related to, for example, datacommunication, processing and/or storage.

In one aspect, since the transmitter unit 620 is configured to a sealedhousing without a separate replaceable battery compartment, in thismanner, the power supply of the battery 621 is preserved during the postmanufacturing sleep mode prior to use.

In a further aspect, the transmitter unit 620 may be disposed orpositioned on a separate on-body mounting unit that may include, forexample, an adhesive layer (on its bottom surface) to firmly retain themounting unit on the skin of the user, and which is configured toreceive or firmly position the transmitter unit 620 on the mounting unitduring use. In one aspect, the mounting unit may be configured to atleast partially retain the position of the sensor unit 610 in atranscutaneous manner so that at least a portion of the sensor unit isin fluid contact with the analyte of the user. Example embodiments ofthe mounting or base unit and its cooperation or coupling with thetransmitter unit are provided, for example, in U.S. Pat. No. 6,175,752,incorporated herein by reference for all purposes.

In such a configuration, the power supply for the transmitter unit 620may be provided within the housing of the mounting unit such that, thetransmitter unit 620 may be configured to be powered on or activatedupon placement of the transmitter unit 620 on the mounting unit and inelectrical contact with the sensor unit 610. For example, the sensorunit 610 may be provided pre-configured or integrated with the mountingunit and the insertion device such that, the user may position thesensor unit 610 on the skin layer of the user using the insertion devicecoupled to the mounting unit. Thereafter, upon transcutaneouspositioning of the sensor unit 610, the insertion device may bediscarded or removed from the mounting unit, leaving behind thetranscutaneously positioned sensor unit 610 and the mounting unit on theskin surface of the user.

Thereafter, when the transmitter unit 620 is positioned on, over orwithin the mounting unit, the battery or power supply provided withinthe mounting unit is configured to electrically couple to thetransmitter unit 620 and/or the sensor unit 610. Given that the sensorunit 610 and the mounting unit are provided as replaceable componentsfor replacement every 3, 5, 7 days or other predetermined time periods,the user is conveniently not burdened with verifying the status of thepower supply providing power to the transmitter unit 620 during use.That is, with the power supply or battery replaced with each replacementof the sensor unit 610, a new power supply or battery will be providedwith the new mounting unit for use with the transmitter unit 620.

Referring to FIG. 6 again, in one aspect, when the sensor unit 610 isremoved from the transmitter unit 620 (or vice versa), the electricalcontact is broken and the conductivity bar/trace 611 returns to an opencircuit. In this case, the transmitter unit 620 may be configured, todetect such condition and generate a last gasp transmission sent to theprimary receiver unit 104 (and/or the secondary receiver unit 106)indicating that the sensor unit 610 is disconnected from the transmitterunit 620, and that the transmitter unit 620 is entering a powered down(or low power off) state. And the transmitter unit 620 is powered downinto the sleep mode since the connection to the power supply (that isembedded within the transmitter unit 620 housing) is broken.

In this manner, in one aspect, the processor 624 of the transmitter unit620 may be configured to generate the appropriate one or more data orsignals associated with the detection of sensor unit 610 disconnectionfor transmission to the receiver unit 104 (FIG. 1), and also, toinitiate the power down procedure of the transmitter unit 620. In oneaspect, the components of the transmitter unit 620 may be configured toinclude application specific integrated circuit (ASIC) design with oneor more state machines and one or more nonvolatile and/or volatilememory units such as, for example, EEPROMs and the like.

Referring again to FIGS. 1 and 6, in one embodiment, the communicationbetween the transmitter unit 620 (or 102 of FIG. 1) and the primaryreceiver unit 104 (and/or the secondary receiver unit 106) may be basedon close proximity communication where bi-directional (oruni-directional) wireless communication is established when the devicesare physically located in close proximity to each other. That is, in oneembodiment, the transmitter unit 620 may be configured to receive veryshort range commands from the primary receiver unit 104 (FIG. 1) andperform one or more specific operations based on the received commandsfrom the receiver unit 104.

In one embodiment, to maintain secure communication between thetransmitter unit and the data receiver unit, the transmitter unit ASICmay be configured to generate a unique close proximity key at power onor initialization. In one aspect, the 4 or 8 bit key may be generatedbased on, for example, the transmitter unit identification information,and which may be used to prevent undesirable or unintendedcommunication. In a further aspect, the close proximity key may begenerated by the receiver unit based on, for example, the transmitteridentification information received by the transmitter unit during theinitial synchronization or pairing procedure of the transmitter and thereceiver units.

Referring again to FIGS. 1 and 6, in one embodiment, the transmitterunit ASIC configuration may include a 32 KHz oscillator and a counterwhich may be configured to drive the state machine in the transmitterunit ASIC. The transmitter ASIC configuration may include a plurality ofclose proximity communication commands including, for example, newsensor initiation, pairing with the receiver unit, and RF communicationcontrol, among others. For example, when a new sensor unit is positionedand coupled to the transmitter unit so that the transmitter unit ispowered on, the transmitter unit is configured to detect or receive acommand from the receiver unit positioned in close proximity to thetransmitter unit. For example, the receiver unit may be positionedwithin a couple of inches from the on-body position of the transmitterunit, and when the user activates or initiates a command associated withthe new sensor initiation from the receiver unit, the transmitter unitis configured to receive the command from the receiver and, in itsresponse data packet, transmit, among others, its identificationinformation back to the receiver unit.

In one embodiment, the initial sensor unit initiation command does notrequire the use of the close proximity key. However, other predefined orpreconfigured close-proximity commands may be configured to require theuse of the 8 bit key (or a key of a different number of bits). Forexample, in one embodiment, the receiver unit may be configured totransmit a RF on/off command to turn on/off the RF communication moduleor unit in the transmitter unit 102. Such RF on/off command in oneembodiment includes the close proximity key as part of the transmittedcommand for reception by the transmitter unit.

During the period that the RF communication module or unit is turned offbased on the received close proximity command, the transmitter unit doesnot transmit any data, including any glucose related data. In oneembodiment, the glucose related data from the sensor unit which are nottransmitted by the transmitter unit during the time period when the RFcommunication module or unit of the transmitter unit is turned off maybe stored in a memory or storage unit of the transmitter unit forsubsequent transmission to the receiver unit when the transmitter unitRF communication module or unit is turned back on based on the RF-oncommand from the receiver unit. In this manner, in one embodiment, thetransmitter unit may be powered down (temporarily, for example, duringair travel) without removing the transmitter unit from the on-bodyposition.

FIG. 7 is a flowchart illustrating data communication using closeproximity commands in the data monitoring and management system of FIG.1 in accordance with one embodiment of the present invention. Referringto FIG. 7, the primary receiver unit 104 (FIG. 1) in one aspect may beconfigured to retrieve or generate a close proximity command (710) fortransmission to the transmitter unit 102. To establish the transmissionrange (720), the primary receiver unit 104 may be positioned physicallyclose to (that is, within a predetermined distance from) the transmitterunit 102. For example, the transmission range for the close proximitycommunication may be established at approximately one foot distance orless between the transmitter unit 102 and the primary receiver unit 104.When the transmitter unit 102 and the primary receiver unit 104 arewithin the transmission range, the close proximity command, uponinitiation from the receiver unit 104 may be transmitted to thetransmitter unit 102 (730).

Referring back to FIG. 7, in response to the transmitted close proximitycommand, a response data packet or other responsive communication may bereceived (740). In one aspect, the response data packet or otherresponsive communication may include identification information of thetransmitter unit 102 transmitting the response data packer or otherresponse communication to the receiver unit 104. In one aspect, thereceiver unit 104 may be configured to generate a key (for example, an 8bit key or a key of a predetermined length) based on the transmitteridentification information (750), and which may be used in subsequentclose proximity communication between the transmitter unit 102 and thereceiver unit 104.

In one aspect, the data communication including the generated key mayallow the recipient of the data communication to recognize the sender ofthe data communication and confirm that the sender of the datacommunication is the intended data sending device, and thus, includingdata which is desired or anticipated by the recipient of the datacommunication. In this manner, in one embodiment, one or more closeproximity commands may be configured to include the generated key aspart of the transmitted data packet. Moreover, the generated key may bebased on the transmitter ID or other suitable unique information so thatthe receiver unit 104 may use such information for purposes ofgenerating the unique key for the bi-directional communication betweenthe devices.

While the description above includes generating the key based on thetransmitter unit 102 identification information, within the scope of thepresent disclosure, the key may be generated based on one or more otherinformation associated with the transmitter unit 102, and/or thereceiver unit combination. In a further embodiment, the key may beencrypted and stored in a memory unit or storage device in thetransmitter unit 102 for transmission to the receiver unit 104.

FIG. 8 is a flowchart illustrating sensor insertion detection routine inthe data monitoring and management system of FIG. 1 in accordance withone embodiment of the present invention. Referring to FIG. 8, connectionto an analyte sensor is detected (810, based on for example, a power upprocedure where the sensor conduction trace 611 (FIG. 6) is configuredto establish electrical contact with a predetermined one or more contactpoints on the transmitter unit 102. That is, when the sensor unit 101(for example, the electrodes of the sensor) is correspondingly connectedto the contact points on the transmitter unit 102, the transmitter unit102 is configured to close the circuit connecting its power supply (forexample, the battery 621 (FIG. 6)) to the components of the transmitterunit 102 and thereby exiting the power down or low power state intoactive or power up state.

In this manner, as discussed above, in one aspect, the transmitter unit102 may be configured to include a power supply such as a battery 621integrally provided within the sealed housing of the transmitter unit102. When the transmitter unit 102 is connected or coupled to therespective electrodes of the analyte sensor that is positioned in atranscutaneous manner under the skin layer of the patient, thetransmitter unit 102 is configured to wake up from its low power orsleep state (820), and power up the various components of thetransmitter unit 102. In the active state, the transmitter unit 102 maybe further configured to receive and process sensor signals receivedfrom the analyte sensor (FIG. 1) (830), and thereafter, transmit theprocessed sensor signals (840) to, for example, the receiver unit 104(FIG. 1).

Accordingly, in one aspect, the sensor unit 610 (FIG. 6) may be providedwith a conduction trace 611 which may be used to wake up or exit thetransmitter unit from its post manufacturing sleep mode into an activestate, by for example, establishing a closed circuit with the powersupply provided within the transmitter unit 102.

FIG. 9 is a flowchart illustrating sensor removal detection routine inthe data monitoring and management system of FIG. 1 in accordance withone embodiment of the present invention. Referring to FIG. 9, when thesensor removal is detected (910) for example, based on detaching orremoving the transmitter unit 102 that was in contact with the sensorunit 101, one or more status signal is generated (920), that includes,for example, an indication that the sensor removal state has beendetected, and/or an indication that the transmitter unit 102 will entera sleep mode or a powered down status. Thereafter, the generated statussignal in one aspect is transmitted, for example, to the receiver unit104 (930), and the transmitter unit 102 is configured to enter the powerdown mode or low power sleep mode (940).

In this manner, in one aspect, when the transmitter unit 102 isdisconnected with an active sensor unit 101, the transmitter unit 102 isconfigured to notify the receiver unit 104 that the sensor unit 101 hasbeen disconnected or otherwise, signals from the sensor unit 101 is nolonger received by the transmitter unit 102. After transmitting the oneor more signals to notify the receiver unit 104, the transmitter unit102 in one embodiment is configured to enter sleep mode or low powerstate during which no data related to the monitored analyte level istransmitted to the receiver unit 104.

FIG. 10 is a flowchart illustrating the pairing or synchronizationroutine in the data monitoring and management system of FIG. 1 inaccordance with one embodiment of the present invention. Referring toFIG. 10, in one embodiment, the transmitter unit 102 may be configuredto receive a sensor initiate close proximity command (1010) from thereceiver unit 104 positioned within the close transmission range. Basedon the received sensor initiate command, the transmitter unitidentification information may be retrieved (for example, from anonvolatile memory) and transmitted (1020) to the receiver unit 104 orthe sender of the sensor initiate command.

Referring back to FIG. 10, a communication key, which may be optionallyencrypted, is received (1030) in one embodiment, and thereafter, sensorrelated data is transmitted with the communication key on a periodicbasis such as, every 60 seconds, five minutes, or any suitablepredetermined time intervals (1040).

Referring now to FIG. 11, a flowchart illustrating the pairing orsynchronization routine in the data monitoring and management system ofFIG. 1 in accordance with another embodiment of the present invention isshown. That is, in one aspect, FIG. 11 illustrates the pairing orsynchronization routine from the receiver unit 104. Referring back toFIG. 11, the sensor initiate command is transmitted to the transmitterunit 102 (1110) when the receiver unit 104 is positioned within a closetransmission range. Thereafter, in one aspect, the transmitteridentification information is received (1120) for example, from thetransmitter unit that received the sensor initiate command. Thereafter,a communication key (optionally encrypted) may be generated andtransmitted (1130) to the transmitter unit.

In the manner described above, in one embodiment, a simplified pairingor synchronization between the transmitter unit 102 and the receiverunit 104 may be established using, for example, close proximity commandsbetween the devices. As described above, in one aspect, upon pairing orsynchronization, the transmitter unit 102 may be configured toperiodically transmit analyte level information to the receiver unit 104for further processing.

FIG. 12 is a flowchart illustrating the power supply determination inthe data monitoring and management system of FIG. 1 in accordance withone embodiment of the present invention. That is, in one embodiment,using a counter, the receiver unit 104 may be configured to determinethe power supply level of the transmitter unit 102 battery so as todetermine a suitable time for replacement of the power supply or thetransmitter unit 102 itself. Referring to FIG. 12, periodic datatransmission is detected (1210), and a corresponding count in thecounter is incremented for example, by one with each detected datatransmission (1220). In particular, a Hobbs counter may be used in therolling data configuration described above to provide a count that isassociated with the transmitter unit data transmission occurrence.

Referring to FIG. 12, the updated or incremented count stored in theHobbs counter is periodically transmitted (1230) in the data packet fromthe transmitter unit 102 to the receiver unit 104. Moreover, theincremented or updated count may be stored (1240) in a persistentnonvolatile memory unit of the transmitter unit 102. Accordingly, basedon the number of data transmission occurrences, the battery power supplylevel may be estimated, and in turn, which may provide an indication asto when the battery (and thus the transmitter unit in the embodimentwhere the power supply is manufactured to be embedded within thetransmitter unit housing) needs to be replaced.

Moreover, in one aspect, the incremented count in the Hobbs counter isstored in a persistent nonvolatile memory such that, the counter is notreset or otherwise restarted with each sensor unit replacement.

FIG. 13 is a flowchart illustrating close proximity command for RFcommunication control in the data monitoring and management system ofFIG. 1 in accordance with one embodiment of the present invention.Referring to FIG. 13, a close proximity command associated withcommunication status, for example is received (1310). In one aspect, thecommand associated with the communication status may include, forexample, a communication module turn on or turn off command for, forexample, turning on or turning off the associated RF communicationdevice of the transmitter unit 102. Referring to FIG. 13, thecommunication status is determined (1320), and thereafter, modifiedbased on the received command (1330).

That is, in one aspect, using one or more close proximity commands, thereceiver unit 104 may be configured to control the RF communication ofthe transmitter unit 102 to, for example, disable or turn off the RFcommunication functionality for a predetermined time period. This may beparticularly useful when used in air travel or other locations such ashospital settings, where RF communication devices need to be disabled.In one aspect, the close proximity command may be used to either turn onor turn off the RF communication module of the transmitter unit 102,such that, when the receiver unit 104 is positioned in close proximityto the transmitter unit 102, and the RF command is transmitted, thetransmitter unit 102 is configured, in one embodiment, to either turnoff or turn on the RF communication capability of the transmitter unit102.

FIG. 14 is a flowchart illustrating analyte sensor identificationroutine in accordance with one embodiment of the present invention.Referring to FIG. 14, periodically, sensor counter information isreceived (1410), for example included as rolling data discussed above.The received sensor counter information may be stored in one or morestorage units such as a memory unit. When the sensor counter informationis received, a stored sensor counter information is retrieved (1420),and the retrieved sensor counter information is compared with thereceived sensor counter information (1430). Based on the comparisonbetween the retrieved sensor counter information and the received sensorcounter information, one or more signal is generated and output (1440).

That is, in one aspect, the sensor counter in the transmitter unit 102may be configured to increment by one with each new sensor replacement.Thus, in one aspect, the sensor counter information may be associatedwith a particular sensor from which monitored analyte level informationis generated and transmitted to the receiver unit 104. Accordingly, inone embodiment, based on the sensor counter information, the receiverunit 104 may be configured to ensure that the analyte related data isgenerated and received from the correct analyte sensor transmitted fromthe transmitter unit 102.

An analyte monitoring device in one embodiment includes a counter, and adata processing section coupled to the counter, the data processingsection configured to increment a count stored in the counter based on adetection of an analyte sensor.

The counter may include a nonvolatile memory unit.

The data processing section may include a communication module totransmit data related to the count.

A control device for communicating with an analyte monitoring unit inone embodiment includes a data communication section configured toperiodically receive data including a count information related to ananalyte sensor associated with the received data, and a processing unitcoupled to the data communication section to process the received data,the processing unit further configured to compare the count informationin each data periodically received, and when it is determined that thecount information of the periodically received data is different, theprocessing unit is configured to generate one or more signals related tothe status of the analyte sensor.

In one aspect, the one or more signals generated may include a commandto disable the data communication section.

The one or more signals generated may be provided to a user.

The device in a further aspect may include a display unit and where theone or more signals generated is displayed on the display unit.

In yet another aspect, the one or more signals output may include one ormore of a visual indicator, an audible indicator or a vibratoryindicator.

A method in accordance with yet another embodiment includes detecting ananalyte sensor, updating a count associated with the detected analytesensor, and transmitting the updated count.

The method may include storing the updated count.

Additionally, the method may include detecting a further analyte sensor,further updating the count associated with the detected further analytesensor, and transmitting the further updated count.

A method in accordance with still another embodiment includesperiodically receiving data including a count information related to ananalyte sensor associated with the received data, and comparing thecount information in each data periodically received, and when it isdetermined that the count information of the periodically received datais different, generating one or more signals related to the status ofthe analyte sensor.

The one or more signals generated may include a command to disable datacommunication.

The method may also include providing the one or more signals generatedto a user, and also, include outputting the one or more signalsgenerated.

In still a further aspect, the method may include storing the countinformation.

The status of the analyte sensor may include a new analyte sensordetection.

Additionally, the method may include prompting a user to replace theanalyte sensor.

Various other modifications and alterations in the structure and methodof operation of this invention will be apparent to those skilled in theart without departing from the scope and spirit of the invention.Although the invention has been described in connection with specificpreferred embodiments, it should be understood that the invention asclaimed should not be unduly limited to such specific embodiments. It isintended that the following claims define the scope of the presentinvention and that structures and methods within the scope of theseclaims and their equivalents be covered thereby.

1. A glucose monitoring device, comprising: a glucose sensor fortranscutaneous positioning under a skin layer, at least a portion of theglucose sensor in fluid contact with interstitial fluid; a memory; adata processing section operatively coupled to the glucose sensor andthe memory, wherein the data processing section: establishes acommunication range with a remote device when the remote device ispositioned within a predetermined distance from the glucose monitoringdevice; and determines when the glucose sensor is transcutaneouslypositioned and initialized, and based on the determination, transitionsa sensor status data bit stored in the memory from a first state to asecond state; and a communication module operatively coupled to the dataprocessing section that transmits the sensor status data bit to theremote device when the remote device is placed within the establishedcommunication range.
 2. The device of claim 1 wherein the sensor statusdata bit is used to verify the transcutaneous positioning andinitialization of the glucose sensor.
 3. The device of claim 1 whereinthe data processing section transitions the sensor status data bit froma “1” to a “0” or from a “0” to a “1”.
 4. The device of claim 1 whereinthe sensor status data bit corresponds to a sensor connection status ora sensor removal status.
 5. The device of claim 1 wherein the transitionof the sensor status data bit from the first state to the second stateactivates a power up or a power down routine.
 6. The device of claim 1wherein the transition of the sensor status data bit from the firststate to the second state corresponds to the transcutaneous positioningand initialization of the glucose sensor, and triggers a power uproutine.
 7. The device of claim 1 wherein the transition of the sensorstatus data bit from the first state to the second state corresponds toa detection of a sensor removal, and triggers a power down routine. 8.The device of claim 1 wherein the data processing section generates anidentification key.
 9. The device of claim 8 wherein the communicationmodule transmits the generated identification key when the remote deviceis placed within the established communication range.
 10. A glucosemonitoring system, comprising: a glucose sensor for transcutaneouspositioning under a skin layer, at least a portion of the glucose sensorin fluid contact with interstitial fluid; a control device; a glucosemonitoring device operatively coupled to the glucose sensor and thecontrol device, the glucose monitoring device comprising: a memory; adata processing section operatively coupled to the glucose sensor, thecontrol device, and the memory, wherein the data processing section:establishes a communication range with the control device when thecontrol device is positioned within a predetermined distance from theglucose monitoring device; and determines when the glucose sensor istranscutaneously positioned and initialized, and based on thedetermination, transitions a sensor status data bit stored in the memoryfrom a first state to a second state; and a communication moduleoperatively coupled to the data processing section that transmits thesensor status data bit to the control device when the control device isplaced within the established communication range.
 11. The system ofclaim 10 wherein when the control device determines that the receivedsensor status data bit is different than a stored sensor status databit, the control device generates one or more signals related to thestatus of the transcutaneously positioned glucose sensor including theidentity of the transcutaneously positioned glucose sensor.
 12. Thesystem of claim 11 wherein the generated one or more signals is output.13. The system of claim 12 wherein the control device includes a displayunit that displays the generated one or more signals.
 14. The system ofclaim 10 wherein the sensor status data bit corresponds to a sensorconnection status or a sensor removal status.
 15. The system of claim 10wherein the data processing section generates an identification key. 16.The system of claim 15 wherein the communication module transmits thegenerated identification key when the control device is placed withinthe established communication range.
 17. The system of claim 16 whereinthe identification key corresponds to the identity of thetranscutaneously positioned glucose sensor.
 18. The system of claim 17wherein the control device includes a display unit that displays one ormore signals related to the identification of the transcutaneouslypositioned glucose sensor.